BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HBV

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·M6-C Artificial Cervical Disc

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·TruSight Oncology Comprehensive

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE HIGHLY COHESIVE ANATOMICALLY SILICONE-FILLED BREAST IMPLANTS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony™ Extended Range Of Vision Intraocular Lens

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYSHAPE BREAST IMPLANTS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Simplera (TM) System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

    Intrasaccular Flow Disruption Device

    FDA Pre-Market Approval
    FDA Class 3 ·WEB Aneurysm Embolization System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Ballon

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Coronary Stent Systems

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Sapien 3 Transcatheter Heart Valve